Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, ensuring environmental monitoring programs are defined and validated
Job Summary
Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, ensuring environmental monitoring programs are defined and validated.
Plan and witness IQ/OQ/PQ for critical assets, including communication with equipment suppliers or third-party validation service providers.
Draft and maintain validation master plan (VMP), protocols, reports, SOPs, and risk assessments, ensuring controlled documentation and readiness for inspections.
Matching Summary
Coordinate qualification of cleanrooms, HVAC, process gases, and PW/PS systems, ensuring environmental monitoring programs are defined and validated.
Skills & Requirements
Must-have
Facility & Utilities Qualification
Equipment Qualification IQ/OQ/PQ
Aseptic process stimulation
Validation documentation and compliance
Risk management for sterility
Audit and inspection readiness
Nice-to-have
Continuous improvement mindset
Collaboration and ownership
Working in high-stakes environments
Key Requirements
5+ years in GMP cell therapy, biologics, or sterile manufacturing
2+ years as validation project manager or team manager
Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
Familiarity with CFDA GMP, EU GMP (Annex 1), PIC/S, US FDA guidance